Investigation: visual inspection during the investigation, no significant deformations or damage of the valves was determined.Permeability test a permeability test has shown that all components are permeable.The drained liquid was clear.Computer controlled test to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 is operating not within the accepted tolerance in the horizontal position.The shuntassistant is operating within the specified tolerances in both the horizontal as well as the vertical positions.An accelerated outflow of progav 2.0 could be determined.Adjustment test the progav 2.0 was tested and is not adjustable.Braking force and brake function test the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection after dismantling of the valves, deposits were found in both.To make the proteins / deposits in the shunt system more visible, they were colored using a staining solution.Results based on our investigation results, we can determine an accelerated outflow and a non-adjustability at the progav 2.0.The visible deposits in the valve may have led to the functional impairment.Deposits caused by substances naturally present in the patient's bodies, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.Also, we can determine visible deposits at the shuntassistant.The deposits had no effect of the valve upon the specifications at the time of the examination.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
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